1. The Field of the Invention
This invention relates to an improved anti-microbial agent. More particularly, this invention is specifically directed to an additive for water-based polymerized compositions and provides an ethylene glycol-based composition for topical anti-viral treatment of mucocutaneous tissue.
2. The Background Art
Ethylene glycol, an inexpensively available organic chemical, is readily polymerized. Polyethylene glycol (PEG) is widely used in our society. A PEG polymer with the molecular weight of 968, commonly referred to as nonoxynol-9 or N-9, is a viscous liquid that has long been used as a lubricant and spermicide in concentrations of 2%-5% in over-the-counter (OTC) preparations, e.g., Ortho-creme, Gentersal, Delfen. Products known commercially as ViroNox-9 and aidsPLUS+ marketed by MicroBio Products, Inc. of Tempe, Ariz. and Medical Diagnostic Technologies, Inc. dba MeDiTech of Ventura, Calif. respectively, though directed toward cleansing of body surfaces based on other active ingredients, also contain N-9 in concentrations of approximately 2% and are known to provide additional protection against microbiological contamination. The safety, absence of toxicity and freedom from any harmful side effects of these preparations is attested to by long, continued and repeated use.
The spermicide N-9 has been shown to be virucidal and to reduce the frequency of infections due to both viral and bacterial sexually transmitted diseases. It has been suggested that this anti-viral action of N-9 may be the reason why women who use spermicides are far less likely to have cervical cancer in view of the fact that a leading cause of cervical cancer is almost undoubtedly herpes virus. A recent review of scientific archival reports by B. North in Journal of Reproductive Medicine, 33:307, 1988, concludes that the advice of former U.S. Surgeon General Everett Koop be followed for widespread use of N-9 in contraceptive devices as an aid in reducing risk from bacterial and viral infection passed by sexual intercourse. Of course, this includes herpes infection.
For critical evaluations or comparison considerations of prophylactic substances to be used against an infectious disease agent it is necessary to have certain basic information; for example, the infectiousness of the agent, the extent of the disease in the population under test, the extent and significance of latency of the disease to treatment. In these regards, among diseases of great infectiousness, the virus disease herpes is an example. Other virus diseases of great infectiousness which we have overcome by immunization are smallpox, measles and poliomyelitis. To date, no effective immunization against herpes has been developed. Major reasons for this failure may include the facts that initial infections with herpes are usually mild or inapparent, that the disease becomes latent (i.e., occult or inapparent, present but inactive), and that the disease is widespread.
The mildness of the usual infection or recurrences may not offer a significant public health hazard but such recurrences are of major social significance whether of oral or genital appearance.
The widespread nature of the disease is well understood. Critical estimates of the extent of the disease is well documented. Critical estimates of the extent of the disease are based on serologic test and postmortem evidence. Serologic testing shows that more than 90% of adults have been infected with herpes, according to Rivers and Horsfall in Viral and Rickettsial Infections of Man, 3rd ed., p. 778.
Although the mechanism of herpes latency remains unknown, the evidence is strong that the virus remains latent, after primary infection, in neural tissue. Reactivation from latency involves return of virus through nerve tissue to peripheral cutaneous cells. As is so obvious, the cells of the mucocutaneous oral region are a preferred site for boisterous growth of the virus. The herpes virus is readily cultured from the lesions.
Virus is found free in blister fluid and tissue in herpetic lesions. It is apparent that the virus enters, reproduces and destroys new cutaneous cells that it encounters. It follows that stopping the passage of virus from neural cells or infected cutaneous cells to uninfected cells will block the progress of a lesion and so result in more rapid healing.